Senior Director of Capture responsible for strategic development in defense sector for Pivotal's eVTOL aircraft. Fostering relationships with military and government agencies to secure opportunities.
About the role
- Director of ICSR Knowledge & Process Optimization at Regeneron driving compliance and efficiency in safety report processing. Ensuring high-quality procedures and collaborating with cross-functional teams.
Responsibilities
- Develop, maintain, and continuously improve global procedures, standards, and tools for ICSR processing
- Ensure end-to-end ICSR process robustness from intake through reporting
- Drive harmonized procedures, risk-based quality controls, and technology-enabled automation
- Partner with various teams for timely compliance with global regulations
- Map end-to-end processes and identify waste, bottlenecks, and process failures
- Define and review key performance indicators for training compliance and effectiveness
- Curate and maintain the ICSR Knowledge Base
- Standardize role-based training and certification for internal teams and vendors
- Oversee readiness for internal audits and Health Authority inspections
Requirements
- Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required
- Minimum of 12 years of experience in safety and safety reporting
- Equivalent combination of relevant education and experience
- Computer literacy and experience working with Microsoft Office (Word, Excel, PowerPoint) required
- Excellent knowledge of Argus and its applications
- Excellent verbal and written communication skills required
- Excellent interpersonal and organizational skills required
- Ability to work independently, prioritize effectively and work in a matrix team environment required
- Ability and willingness to travel domestically as required.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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